Manager, Manufacturing Operations

Manufacturing Greenville, North Carolina


Description

Position Overview

This position manages resources to ensure all manufacturing/packaging systems, processes, equipment and final pharmaceutical products meet or exceed manufacturing standards, regulatory requirements, and business objectives.  This role will manage the production supervisors (and teams) across multiple shifts within manufacturing/packaging.

Key Responsibility Areas

  • Business Acumen:  Apply understanding of pharmaceutical organization and production operations to provide guidance on best business practices
  • People Development:  Ensure the career growth of team members by building systems and processes to ensure ongoing training and development
  • People Leadership:  Lead in the development of a culture, and supporting systems, to drive open communication, participation, and intra/inter-departmental idea-sharing in order to build an engaged team; advance and model Mayne Pharma values and leadership commitments; assure the highest levels of quality, compliance, and integrity are adhered to in all interactions
  • Quality Management:  Lead investigation process for eQMS system to ensure quality and compliance

Specific Responsibilities                       

Responsibilities include, but are not limited to:

  • Coordinate with Planning and Scheduling to develop an executable schedule to meet company needs
  • Communicate and ensure understanding of area objectives, schedules, procedures and issues
  • Implement and drive performance metrics that related to Right First Time (RFT) goals
  • Partner with Operations Administration Management to develop and maintain metrics to ensure a holistic approach to meeting site RFT goals
  • Conduct Gemba walks to monitor activities on the floor and accomplish area objectives as well as to identify and resolve issues
  • Evaluate deviations and trends to assure the quality and integrity of equipment, processes, and final products
  • Work cross functionally with area leaders in the resolution of daily production/equipment issues, improving equipment and processes, and establishing metrics
  • Proactively interact with support functions to ensure achievement of production schedule and overall business objectives
  • Ensure that the production groups are properly trained and employees perform duties according to approved Manufacturing policies, Standard Operating Procedures, guidelines for Safety, and all applicable current Good Manufacturing Practices
  • Ensure ongoing performance and coaching dialogue between supervisors and team members

Key Competencies/Requirements

  • Agile & Flexible: Leads and embraces change; fosters innovation by challenging the status quo and initiating new ways of working
  • Celebrator: Embraces a culture of action; sets challenges and achieves results; celebrates and rewards achievements of team members
  • Communicator/Collaborator: Builds shared meaning through open and respectful communication. Engages stakeholders in pertinent conversations, and creates an atmosphere that is inclusive and consultative
  • Enforcing Compliance and Policy: Enforces laws, rules, and regulations, and initiates enforcement actions in a way that the public perceives as fair, objective, and reasonable
  • Leads Self: Maximizes personal potential by focusing on ongoing professional growth; takes initiative, honors promises, and acts with courage
  • People Developer: Empowers, inspires, and challenges team members; fosters high performance and development
  • Project Management: Strong organizational skills, ability to define, delineate roles and responsibilities effectively; plan well, flexible and able to facilitate change, optimize quality and productivity as projects progress
  • Purpose Driven: Drives vision and purpose by creating and contributing to strategic direction; aligns priorities to organizational goals
  • Solutions Focused: Solves problems once and simplifies issues; makes problems visible and acts decisively
  • Team Builder: Builds and optimizes a high performing team; creates a sense of belonging and connectivity among team members

 Qualifications

  • Bachelor’s degree in Engineering or science-related field with at least 5 years of relevant experience
  • Associate degree with at least 7 years of relevant experience
  • High school diploma or equivalent with at least 8 years of relevant experience
  • At least 5 years of pharmaceutical production experience with 3 years of supervisory experience
  • Demonstrated ability to motivate employees and management skills (e.g. business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution)
  • Thorough knowledge of cGMPs and other government regulations appropriate to pharmaceutical manufacturing

Physical Requirements

  • Majority of work day is performed while sitting, standing, walking
  • Some exposure to hazardous chemicals, other active chemical ingredients, dust, fumes, and gases
  • Requires ability to occasionally lift items in excess of 20 pounds
  • Ability to occasionally stoop, bend, twist, push, pull, and have full range of motion in upper and lower extremities
  • Ability to handle and manipulate objects using hands and arms

Equal Employment Opportunity and Employment Eligibility 

Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Mayne Pharma is an E-Verify employer.